Food and drug administration

DR. CHAMPLIN: Richard Champlin from the M.D. Anderson Cancer Center and the Chairman of the Blood and Marrow Transplant Department.

DR. SAUSVILLE: I'm Ed Sausville from the National Cancer Institute and the Developmental Therapeutics Program, and my interest is in the development of new drugs for the treatment of cancer.

DR. VOSE: Julie Vose from the University of Nebraska Medical Center, and my research interests are in lymphoma and hematologic malignancies, transplantation, and immunotherapy.

DR. SALOMON: Again, as I said, Dan Salomon, Scripps Research Institute. My interests are in transplantation, xenotransplantation, and gene therapy.

MS. DAPOLITO: Gail Dapolito, Executive Secretary for the committee.

I'd also like to announce that Dr. Richard Goldsby from Amherst College is participating on the speaker phone this morning.

I'd also like to take this opportunity to introduce Ms. Rosanna Harvey, the committee management specialist. As the committee knows, Rosanna was instrumental in the preparations for today's meetings, and as usual, she'll be around all day to help out with any questions.

Thank you.

DR. BROUDY: I'm Virginia Broudy from the University of Washington, and my interest is in hematopoietic growth factors.

MS. MEYERS: Abbey Meyers, President of the National Organization for Rare Disorders, which is NORD. I'm a former member of the committee I believe and a consultant today for consumers.

DR. MILLER: Carole Miller from Johns Hopkins. My interests are in hematologic malignancies and bone marrow transplant, clinical.

DR. STEIN: Kathryn Stein, Director of the Division of Monoclonal Antibodies, CBER.

DR. SCHWIETERMAN: Bill Schwieterman, Chief of the Immunology and Infectious Disease Branch, CBER.

DR. SIEGEL: Jay Siegel, Office of Therapeutics at CBER.

DR. SALOMON: Yes. I'd also like to add that Dr. Hugh Auchincloss from Harvard Medical School will be joining us in a few minutes.

Next Gail will read into the record the administrative remarks.

MS. DAPOLITO: This announcement is made part of the record at this meeting of the Biological Response Modifiers Advisory Committee on July 15.

Pursuant to the authority granted under the committee charter, the Director of the FDA's Center for Biologics Evaluation and Research has appointed Dr. Virginia Broudy, Ms. Abbey Meyers, and Dr. Julie Vose as temporary voting members for the committee discussions.

Based on the agenda made available and on relevant data reported by participating members and consultants, it has been determined that all financial interests in firms regulated by the Center for Biologics Evaluation and Research that may be affected by the committee's discussions have been considered. The following participants have been granted waivers, in accordance with 18 U.S.C. 208, which permits them to participate fully in the committee discussions: Drs. Hugh Auchincloss, Virginia Broudy, Richard Champlin, Carole Miller, and Julie Vose. Dr. Michael O'Fallon has requested to be recused from the discussion of the report of the Xenotransplantation Subcommittee.

In the event that the discussions involve specific products or firms not on the agenda for which FDA's participants have a financial interest, the participants are aware of the need to exclude themselves from such involvement, and their exclusion will be noted for the public record.

Screenings were conducted to prevent any appearance, real or apparent, of conflict of interest in today's committee discussions. Copies of the waivers addressed in this announcement are available by written request under the Freedom of Information Act.

With respect to all other meeting participants, we ask in the interest of fairness that they address any current or previous financial involvement with any firm whose products they wish to comment upon.

DR. SALOMON: Thank you, Gail.

Are there any other comments from the FDA staff we need to deal with?

(No response.)

DR. SALOMON: I'm going to, as Chairman, try and stay on time but, in the same way, allow everybody to participate in the discussion as much as possible.

Obviously, for recording interests, it's going to be important for us, as usual, to make an effort to speak directly into the microphones. I apologize if we have to remind anybody of that. I usually forget myself.

Then I'd like to open up the public hearing. We have one scheduled speaker which is Dr. Thomas Schaible, Senior Director of Immunology and Medical Affairs for Centocor. Welcome, Dr. Schaible.

DR. SCHAIBLE: Thank you. Good morning. We appreciate the opportunity to share our experience at Centocor regarding immune responses to therapeutic biologics.

This morning I'd like to touch upon a few of the key issues revolving around immune responses and, more specifically, share with you our experience with two of our products, Remicade and ReoPro, and then finish up my presentation with some conclusions based upon that experience.

Now, certainly one of the key issues with biologics is their potential antigenicity, and if antibodies develop against these agents, what is the clinical relevance both in terms of safety, whether there are potential allergic reactions or hypersensitivity that may result from these antibodies, but also in terms of efficacy, is there potential for blocking antibodies that may result in reductions in potency of these agents.

I think as a quick background, it's important to recognize that a number of biologic agents, both recombinant molecules, as well as monoclonal antibodies, do develop antibodies at varying incidences as well as magnitudes.